ObesityPhase 3NCT07670416
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
A Phase 3 study testing Enicepatide in people with Obesity and Overweight, run by Hoffmann-La Roche at 21 sites in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Enicepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 21 sitesChina
- Study dates
- 3 Jul 2026to 15 Mar 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m^2) for participants with type 2 diabetes mellitus (T2DM)
- BMI ≥28.0 kg/m^2 or BMI ≥24.0 and <28.0 kg/m^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM
- Agreement to adhere to the contraception requirements
Who cannot join
- History of Type 1 diabetes mellitus (T1DM)
- Obesity induced by other endocrinologic disorders
- Any planned major medical procedure or surgery during the study
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
- Any lifetime history of suicide attempt
- History of any hematologic conditions that may interfere with HbA1c measurement
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- History of acute or chronic pancreatitis or clinically significant gallbladder disease
- Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization
- Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer
- Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1/GIP RAs
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
21 sites in 1 country
China21 sites, 21 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
- Recruiting
The Second Hospital of Jilin University
Changchun, 130041
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, 230601
- Recruiting
The Fourth Affiliated Hospital of Harbin Medical University
Herbin, 150001
- Recruiting
Huai'an First People's Hospital
Huai'an
- Recruiting
Huzhou Central Hospital
Huzhou, 313000
- Recruiting
Jinan Central Hospital
Jinan, 250013
- Recruiting
Hebei Petro China Central Hospital
Langfang, 065000
- Recruiting
Luoyang Third People's Hospital
Luoyang, 471000
- Recruiting
The Affiliated Jiangning Hospital of Nanjing Medical University
Nanjing, 211100
- Recruiting
The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
Ningbo, Zhejiang, 315010
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, 200072
- Recruiting
Shanghai East Hospital
Shanghai, 200120
- Recruiting
Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200336
- Recruiting
Shanghai Fifth People's Hospital Affiliated to Fudan University
Shanghai, 201304
- Recruiting
The People's Hospital of Liaoning Province
Shenyang, 110016
- Recruiting
Shenyang Fifth People Hospital
Shenyang, 110074
- Recruiting
Hebei Medical University - The Second Hospital
Shijiazhuang, 050004
- Recruiting
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, 712000
- Recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
- Recruiting
Zibo Municipal Hospital.
Zibo, 255400
About this study
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.
- Conditions
- Obesity, Overweight, Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Enicepatide, Placebo
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnicepatideCombination product
Also called RO7795068, CT-388, RG6640
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
PlaceboCombination product
Participants will receive matching placebo via SC injection as per the schedule in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Enicepatide Dose 1 | Experimental | Participants will receive enicepatide Dose 1. Receives: Combination Product: Enicepatide |
| Enicepatide Dose 2 | Experimental | Participants will receive enicepatide Dose 2. Receives: Combination Product: Enicepatide |
| Enicepatide Dose 3 | Experimental | Participants will receive enicepatide Dose 3. Receives: Combination Product: Enicepatide |
| Placebo | Placebo comparator | Participants will receive matching placebo. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight at Week 52
Measured: Baseline through Week 52
Secondary outcomes (39)
Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52
Measured: At Week 52
Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52
Measured: At Week 52
Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52
Measured: At Week 52
Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3
Measured: At Week 52
Change From Baseline in Body Weight at Week 52
Measured: Baseline through Week 52
Change From Baseline in Waist Circumference at Week 52
Measured: Baseline through Week 52
Change From Baseline in Fasting Glucose at Week 52
Measured: Baseline through Week 52
Change From Baseline in Fasting Insulin at Week 52
Measured: Baseline through Week 52
Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52
Measured: Baseline through Week 52
Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52
Measured: Baseline through Week 52
Change From Baseline in Triglyceride at Week 52
Measured: Baseline through Week 52
Change From Baseline in Systolic Blood Pressure at Week 52
Measured: Baseline through Week 52
Change From Baseline in the Physical Functioning as Assessed by Short Form 36 Health Survey Acute, Version 2.0 (SF-36 v2 Acute) at Week 52
Measured: Baseline through Week 52
Change From Baseline in Physical Functioning Composite Score as Assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 52
Measured: Baseline through Week 52
Percent Change From Baseline in Body Weight at Week 52 in GLP-1 RA-based Treatment Naive Populations
Measured: Baseline through Week 52
Change From Baseline in Waist-to-Hip Ratio at Week 52
Measured: Baseline through Week 52
Change From Baseline in Waist-to-Height Ratio at Week 52
Measured: Baseline through Week 52
Percentage of Participants With Prediabetes at Baseline Achieving Normoglycemia (Hemoglobin A1c [HbA1c] <5.7%) at Week 52
Measured: At Week 52
Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Domain Scores and Component Summary Scores at Week 52
Measured: Baseline through Week 52
Change From Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Questionnaire Domain Scores and Total Score at Week 52
Measured: Baseline through Week 52
Change From Baseline in Non-HDL Cholesterol at Week 52
Measured: Baseline through Week 52
Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52
Measured: Baseline through Week 52
Change From Baseline in Total Cholesterol at Week 52
Measured: Baseline through Week 52
Change From Baseline in Free Fatty Acids at Week 52
Measured: Baseline through Week 52
Change From Baseline in Diastolic Blood Pressure at Week 52
Measured: Baseline through Week 52
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52
Measured: Baseline through Week 52
Change From Baseline in Serum Uric Acid at Week 52
Measured: Baseline through Week 52
Percentage of Participants Achieving ≥25% Body Weight Loss at Week 52, in Participants Receiving Enicepatide Dose 2 and Dose 3
Measured: Baseline through Week 52
Change From Baseline in Body Mass Index (BMI) at Week 52
Measured: Baseline through Week 52
Percent Change From Baseline in Body Weight by Obesity Class at Week 52
Measured: Baseline through Week 52
Change From Baseline in HbA1c at Week 52 in Participants With T2DM
Measured: Baseline through Week 52
Percentage of Participants With T2DM Achieving HbA1c of <5.7%, ≤6.5% and <7% at Week 52
Measured: At Week 52
Change From Baseline in Total Lean Tissue Volume at Week 52
Measured: Baseline through Week 52
Percent Change From Baseline in Total Lean Tissue Volume at Week 52
Measured: Baseline through Week 52
Change From Baseline in Total Adipose Tissue Volume at Week 52
Measured: Baseline through Week 52
Percent Change From Baseline in Total Adipose Tissue Volume at Week 52
Measured: Baseline through Week 52
Incidence and Severity of Adverse Events, With Severity Determined According to Mild, Moderate, and Severe Criteria
Measured: Baseline to Safety Follow-Up (55 Weeks)
Change From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Measured: Baseline through Week 52
Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score
Measured: Baseline through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start3 Jul 2026
- Primary completion24 Feb 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670416
- Sponsor's protocol ID
- YC46401
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing